Original New Drug Application Approvals by US FDA (1-15 June 2026)

07 Jul 2026
Original New Drug Application Approvals by US FDA (1-15 June 2026)
New drug applications approved by US FDA as of 1-15 June 2026 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

TIOCYSTIN
  • Active Ingredient(s): Tiopronin
  • Strength: 100MG; 200MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Casper Pharma LLC
  • Approval Date: 2 June 2026
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone.
  • Approved Label:  2 June 2026 (PDF)
RANLUSPEC
  • Active Ingredient(s): Ranibizumab-hkdz
  • Strength: 6MG/ML; 10MG/ML
  • Dosage Form(s) / Route(s): Injection
  • Company: Lupin Limited
  • Approval Date: 2 June 2026
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of patients with:
    • Neovascular (Wet) Age-Related Macular Degeneration (AMD)
    • Macular Edema Following Retinal Vein Occlusion (RVO)
    • Diabetic Macular Edema (DME)
    • Diabetic Retinopathy (DR)
    • Myopic Choroidal Neovascularization (mCNV)
  • Approved Label:  2 June 2026 (PDF)
AMBELVIST
  • Active Ingredient(s): Gadoquatrane
  • Strength: 0.5158GM/2ML (257.9MG/ML); 1.93425GM/7.5ML (257.9MG/ML); 2.579GM/10ML (257.9MG/ML); 3.8685GM/15ML (257.9MG/ML); 7.737GM/30ML (257.9MG/ML); 16.7635GM/65ML (257.9MG/ML)
  • Dosage Form(s) / Route(s): Solution;intravenous
  • Company: Bayer Healthcare
  • Approval Date: 12 June 2026
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in:
    • the central nervous system (brain, spine, and associated tissues)
    • the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system)
  • Approved Label:  12 June 2026 (PDF)